Not Much Of A Watchdog

February 06, 2004

Advertisements for prescription drugs often contain warnings written in medical jargon and printed in tiny type.

Now the federal Food and Drug Administration wants pharmaceutical companies to use clear language in larger type, with the most important risk information highlighted. That's a useful goal. Consumers deserve comprehensible information.

But there are a few problems. First, the FDA issued the new rules merely as guidelines. Drug makers are free to ignore them. Second, some of the advice might actually hinder understanding. The FDA gave this example of a possible revised warning: Instead of saying that a drug could cause ``acute liver failure,'' the message might say that the drug ``can affect your liver function.'' That's an improvement?

The FDA has become lax in enforcing federal law barring ``false and misleading'' drug advertising. A recent congressional study found that enforcement actions dropped substantially last year compared with the late 1990s. It took the FDA almost six months, on average, to act against deceptive ads. Moreover, when the FDA did act, it sent warning letters. Not once did it seek an injunction or a fine, even for repeat offenders.

Congress gave the FDA oversight authority to ensure that consumers get trustworthy information about prescription drugs. But the agency shirks this responsibility when it just wags its finger at drug makers. To be effective, the FDA should make its new easier-to-read rules mandatory and hold manufacturers accountable.